Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Set, Administration, Intravascular
510(k) Number K944619
Device Name I.V.I.D. FLUID ADMINISTRATION SET MARKER
Applicant
Advanced Bioresearch Assoc.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Applicant Contact STEVE REIZLER
Correspondent
Advanced Bioresearch Assoc.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Correspondent Contact STEVE REIZLER
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KPE  
Date Received09/20/1994
Decision Date 01/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-